Scale up simulation technology

Using a scale-up simulation technology based on accumulated experiences in chemical engineering, SPERA PHARMA can identify/solve a scale-up challenge in advance, ensuring process robustness and the productivity.

For example, a robust crystallization method for API, with a character of easy oil-downed and a large variation of the distribution of crystal particle size, has been established by our simulation technology. (Cryst. Growth Des., 2014, 14 (11), 6006)

Moreover, a robust and efficient drying process for a hydrate API with high quality in commercial scale has been developed by considering the vacuum drying conditions in detail as a process simulation study. (Separation Process Engineering, 2013, 43, 375)

ItemExamples of simulation technology
  • Predict exothermic control by our unique simulation software which incorporates acquisition of exothermic properties using RC1 and property of on-site reaction tank
  • Scale-up gas absorption reaction
  • Simulate solvent composition of mixed solvents during simple distillation by our unique software
  • Predict concentration time
  • Propose optimal concentration method
  • Scale-up crystallization in consideration of agitation power and time-dependent supersaturation
  • Develop operation to obtain desired crystal form and particle size
  • Support LCM in terms of API development as cocrystal and optimal salt
  • Evaluate various filtration properties and calculate scale-up by our own software (pressured filtration, centrifugal filtration, depth filtration, filter aid filtration)
  • Simulate washing and deliquoring
  • Propose optimal filtration technique
  • Acquire data in consideration of exhaust velocity by our unique drying equipment and calculate prediction at scale
  • Develop drying method to obtain hydrate
  • Reduce amount of solvent which is hard to remove
  • Prevent aggregation in drying
  • Propose optimal milling, scale-up operational condition

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SPERA provides CMC solutions from early-stage through new drug application.

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